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Намерени 4,436 изпитвания Стр. 41 от 222

Набира участници Фаза 4

Caffeine Administration for Preterms: Pharmacokinetics, Utilization and Correlation Inhibiting Nociception Outcome

Primary apnea in preterms newborns

Trial status: Authorised 1. a) Proportion of preterm newborns in whom the concentrations of caffeine and paraxanthine can be reliably measured from saliva samples., 2. a) Salivary caffeine concentrations over time b) Relationship between caffeine dose and concentration over time., 3. a) Relationship between salivary caffeine concentrations and: • Frequency (Apnea of Prematurity events per 24 hours) and severity of apneic episodes (detail in Section 6.7.3.) • The need for respiratory support, considering its duration and type • Time to successful withdrawal of caffeine therapy, 4. a) Incidence of prematurity-related complications: BPD, ROP, PDA, periventricular hemorrhage/intraventricular hemorrhage (PVH/IVH), periventricular leukomalacia (PVL), posthemorrhagic hydrocephalus (PHH), neonatal seizures, and others., 5. a) Evaluation of pain assessment scores (COMFORTneo Scale) and vital function parameters (heart rate, blood pressure) in relation to concentration and exposure duration., 6. a) Comparison of the incidence and severity of adverse events of special interest (AESI) related to caffeine therapy in relation to caffeine concentration levels: • CVS: Tachycardia (for definition see Section 6.7.2) • CNS: Convulsion, brain injury, irritability, jitters, shaking • GIT: Feeding intolerance, necrotizing enterocolitis • Investigations: Urine output increased, Exploratory endpoints 2. a) CYP1A2 metabolic activity (caffeine/paraxanthine ratio in saliva) in both GA subgroups and correlation with caffeine therapy duration. b) Evaluation of the analgesic effect of caffeine in relation to CYP1A2 metabolic activity. c) Relationship between CYP1A2 metabolic phenotype and treatment efficacy or caffeine-related adverse events (e.g., tachycardia, feeding intolerance). a) Exploration of observed caffeine concentration levels in groups of preterm newborns receiving caffeine therapy, stratified by treatment response as defined by the duration of IRS evaluated on Day 11 and at 36 weeks of postmenstrual age (PMA).

Начало: 09.02.2026

Czech Republic Masarykova Univerzita 2025-523475-33-00

Набира участници Фаза 3

A Study of Brenipatide in Adult Participants With Major Depressive Disorder

Depressive Disorder, Major

This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms. The trial is divided into three periods as follows: a screening period that will last approximately 1 month, a treatment period that will last a minimum of 12 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if depression symptoms worsen or if withdrawal from the study occurs for any reason.

Начало: 09.02.2026 Край: 01.02.2028 Възраст: 18–75 г. Лечение

Australia, Brazil, Canada +12 Eli Lilly and Company NCT07412756

Набира участници

The International Spinal Cord Injury Blood Biomarker Longitudinal Evaluation (I-SCRIBBLE) Study

Spinal Cord Injury

To determine the accuracy of serum NF-L and GFAP levels (ie the biomarkers) at different time points postinjury for predicting the severity of neurologic impairment at 6 months postinjury as either motor complete (AIS grade A/B) or motor incomplete (AIS grade C/D) a group of patients who suffer traumatic spinal fracture and/or dislocation of the spinal column but without neurologic injury will be enrolled as non-SCI spine trauma control participants.

Начало: 09.02.2026 Край: 01.12.2029 Възраст: от 19 г.

Australia, Brazil, Chile +5 AO Foundation, AO Spine NCT06839300

Набира участници Фаза 1/2

KEYMAKER-U04 Substudy 04D: A Clinical Study of New Treatments Given With Enfortumab Vedotin and Pembrolizumab in People With Urothelial Cancer (MK-3475-04D/KEYMAKER-U04)

Bladder Cancer

Researchers are looking for new ways to treat people with urothelial cancer (UC) that is locally advanced or metastatic. The standard treatment for locally advanced or metastatic UC is enfortumab vedotin (EV) given with pembrolizumab. The goals of this study are to learn about: * The safety of the study treatment when given with standard treatment and if people tolerate it * The number of people who have the cancer respond (cancer gets smaller or goes away) with the new study treatment when given with standard treatment.

Начало: 09.02.2026 Край: 08.07.2031 Възраст: от 18 г.

Chile, France, Israel +5 Merck Sharp & Dohme LLC NCT07232602

Набира участници Фаза 2

A Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus

Type II Diabetes Mellitus

This study is testing whether a new medication called CX11 works and is safe for participants with type 2 diabetes who have not reached good blood sugar control while taking a steady dose of metformin, with or without a steady dose of an SGLT2 inhibitor, for at least 90 days. The study is being done at multiple medical centers. Participants are assigned by chance (randomized) to different groups, and neither the participants nor the study staff know which group they're in (double-blind). The groups are compared side by side (parallel), and some participants will receive inactive pills (placebo) to help measure the true effect of the study drug. After screening, participants will be randomly placed into one of six groups, with equal chances of being in any group. Each group will receive a different dose of CX11 or a placebo. Treatment will last 24 weeks. After that, all participants will have a 2-week follow-up period to check on safety.

Начало: 06.02.2026 Край: 07.01.2027 Възраст: 18–75 г.

Poland, United States Corxel Pharmaceuticals NCT07340320

Набира участници Фаза 1

Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum

Actinic Keratoses

This study is looking at a new way to treat actinic keratoses, which are rough, scaly spots on the skin caused by long-term sun exposure. These spots are common in older adults and, if not treated, can sometimes develop into a type of skin cancer. Doctors often treat areas with many of these spots by using a prescription cream called 5-fluorouracil (5-FU), which helps remove damaged skin cells. This study is testing whether adding aluminum chloride hexahydrate, a medication commonly used to stop bleeding during skin procedures, can improve how well the cream works. People who take part in this study will receive one of two treatments applied to their skin: Standard treatment with 5% 5-fluorouracil cream, or A combination of 5% 5-fluorouracil cream plus 15% aluminum chloride hexahydrate cream The treatment will be applied for one week. A dermatologist will examine the treated skin areas, count the number of actinic keratoses, and take photographs before treatment begins, shortly after treatment ends, and again about eight weeks later. These visits help researchers compare how well each treatment reduces the number of skin spots over time. The goal of this study is to learn whether adding aluminum chloride hexahydrate to standard treatment helps reduce actinic keratoses more effectively than standard treatment alone.

Начало: 06.02.2026 Край: 01.08.2027 Възраст: 18–50 г.

United States West Virginia University NCT07401277

Набира участници Фаза 3

A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes

Obesity Overweight

The purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes. The study has two phases: a main phase and an extension phase. Participation in the main phase of the study will last about 75 weeks. Participants with prediabetes will continue in the extension phase for another 2 years.

Начало: 06.02.2026 Край: 01.07.2030 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +12 Eli Lilly and Company NCT07321886

Набира участници Фаза 1

A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects

Multiple Myeloma (MM)

The main purpose of the study is to understand the safety and tolerability of cemsidomide when given along with elranatamab in subjects with relapsed or refractory multiple myeloma. The first part of the study will evaluate different dose levels of cemsidomide in combination with elranatamab in a limited number of subjects. Approximately 3 different dose levels of cemsidomide in combination with elranatamab may be explored. Once a dose level is determined safe, additional subjects may be enrolled through expansion of the dose level. This expansion will provide further exploration of the safety and evaluation of preliminary antimyeloma activity. Cemsidomide will be taken orally each cycle for 14 days on/14 days off (1 cycle=28 days). Elranatamab will be administered by subcutaneous injection twice a month. Dexamethasone will be administered weekly until a confirmed response but no longer than 4 cycles.

Начало: 06.02.2026 Край: 01.06.2029 Възраст: от 18 г.

United States C4 Therapeutics, Inc. NCT07280013

Набира участници Фаза 2

A Single Arm, Open Label, Phase 1/2 Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients with Sickle Cell Disease

Sickle Cell Disease

Trial status: Authorised • Incidence of AEs, SAEs, and AEs related to etavopivat (extension period) • Number of premature discontinuations, dose interruptions, and dose reductions (extension period), • Hb response rate at Weeks 12 and 24 (increase of > 1 g/dL from baseline) • Change in Hb from baseline at Weeks 12 and 24, Incidence of VOCs during the 24-week primary treatment period o Number of VOCs o Annualized Rate of VOC, Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale at Weeks 12 and 24 (between 5 to 18 years of age), Change from baseline in time-averaged mean of the maximum velocity (TAMMV) by transcranial Doppler ultrasonography (TCD) (> 2 years of age) • Single-dose: maximum concentration (Cmax), area under the concentration time curve (AUC)0-t, AUC0-inf • Steady-state etavopivat plasma exposure (Cmax,ss, AUCtau,ss, Cavg,ss, Cmin,ss) • Estimated using population PK • Incidence of AEs, SAEs, and AEs related to etavopivat • Number of premature discontinuations, dose interruptions, and dose reductions.

Начало: 06.02.2026

France Novo Nordisk A/S 2024-519881-32-00

Набира участници Фаза 1

Evaluation of the Safety, Tolerability and Pharmacokinetics of HY6725 in Healthy Adult Participants

Healthy

The goal of this clinical trial is to learn the safety, tolerability and pharmacokinetics of single and multiple doses of HY6725 in healthy adult participants. The main questions it aims to answer are: * How is the safety and tolerability following administration of single and multiple doses of HY6725 in healthy adult participants? * What is the PK character of HY6725 following administration of single and multiple doses of HY6725 in healthy adult participants? Researchers will compare HY6725 to a placebo (a look-alike substance that contains no drug) to see if HY6725 is safe and well tolerated. Participants will take HY6725 or a placebo once or twice in single dose group or multiple dose group. And will be follow-up until Day 150.

Начало: 06.02.2026 Край: 01.04.2027 Възраст: 18–55 г. Друго

Australia Newsoara Biopharma Co., Ltd. NCT07262281

Набира участници

Effectiveness and Treatment Patterns of Mavacamten in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan (MANAGE-HCM)

Cardiomyopathy

The purpose of this study is to assess the real-world effectiveness and safety of mavacamten in adults diagnosed with symptomatic obstructive hypertrophic cardiomyopathy (HOCM) receiving cibenzoline in Japan

Начало: 05.02.2026 Край: 31.12.2026 Възраст: от 18 г.

Japan Bristol-Myers Squibb NCT07541833

Набира участници Фаза 3

A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)

Diabetes Mellitus, Type 1

The purpose of this study is to find out if baricitinib can preserve beta-cell function in participants newly diagnosed with type 1 diabetes. Participation in the study will last about 60 weeks.

Начало: 05.02.2026 Край: 01.07.2028 Възраст: 1–35 г. Лечение

Australia, Belgium, Brazil +15 Eli Lilly and Company NCT07222332

Набира участници

Clinical Performance of Bioactive Bulk-Fill in Class II Restorations

Dental Caries

This prospective split-mouth clinical study aims to compare the clinical performance of a bioactive bulk-fill composite with a conventional microhybrid composite in Class II posterior restorations. In each participant, two comparable Class II cavities will be treated using different restorative approaches. In the experimental condition, a bioactive bulk-fill composite (Activa BioACTIVE Bulk Flow) will be placed at the gingival base and covered with a microhybrid composite (Filtek Z250). In the control condition, restorations will be completed entirely with the microhybrid composite (Filtek Z250). Clinical performance will be evaluated according to FDI World Dental Federation criteria at baseline, 6 months, and 12 months. Primary outcomes include marginal adaptation, retention, and overall clinical success of the restorations. Secondary outcomes include surface properties and marginal staining. The split-mouth design allows direct intra-individual comparison, thereby minimizing inter-individual variability and increasing the reliability of the findings. The results of this study are expected to provide evidence on the effectiveness of bioactive bulk-fill composites in improving the clinical performance of posterior restorations.

Начало: 05.02.2026 Край: 30.08.2027 Възраст: 18–50 г.

Turkey (Türkiye) Bezmialem Vakif University NCT07547904

Набира участници Фаза 1/2

A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors

Locally Advanced or Metastatic Malignant Solid Tumors

Specific proteins found in tumors help the tumors spread and grow. People with solid tumors often have a protein called TROP2 in their tumor. ASP2998 is being developed to attach to TROP2 and then attack the tumor cells in people with solid tumors. ASP2998 will either be given by itself, or given together with one or more of standard cancer treatments pembrolizumab, carboplatin, and enfortumab vedotin. This is an early development study to collect information about ASP2998 in people with solid tumors. In this study ASP2998 will be given to humans for the first time. Early development studies are mostly about safety, but also to find the most suitable dose. Other aims are to check if ASP2998 shows signs of reducing tumor growth, to learn how the body processes ASP2998, and to check if there are changes either in the TROP2 protein or in the immune system. The main aim of the study is to check the safety of ASP2998 when given by itself and given with the standard cancer treatments, and how well it is tolerated. People in this study will be adults with locally advanced, unresectable or metastatic solid tumors. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. People's cancer came back or became worse after previous treatment or they couldn't receive treatment. Some people who had previously refused treatment may be able to take part. This will depend on which study treatment they receive. People will either have cancer in the bladder lining (urothelial cancer), non-small cell lung cancer (NSCLC), gastric cancer or cancer where the food pipe joins the stomach (gastroesophageal cancer, or GEJ), or certain types of breast cancer. People cannot take part if the cancer cells have spread to the thin tissue covering the brain and spinal cord (leptomeningeal disease), have symptoms of cancer in the brain or nervous system, or need medicines to suppress their immune system. In this study, ASP2998 will be given to humans for the first time. ASP2998 will either be given by itself, or given together with one or more of standard cancer treatments pembrolizumab, carboplatin and enfortumab vedotin. The standard cancer treatment given will depend on which cancer people have. The study will have 2 parts. In Part 1, different small groups of people will receive lower to higher doses of ASP2998 given by itself or together with one or more of the standard cancer treatments. Any medical problems will be recorded for each dose. This is done to find suitable doses of ASP2998 to use in Part 2. In Part 2, other different small groups will receive suitable doses of ASP2998 worked out from Part 1. ASP2998 will either be given by itself or given together with one or more of the standard cancer treatments. This part will also check how each type of cancer responds to ASP2998 when given by itself or together with the standard cancer treatments. In both parts of the study, safety checks will be done at each visit, and the doctors will continue to check for medical problems throughout the study. ASP2998 will be given slowly through a tube into a vein (infusion). People will continue to receive ASP2998 until their cancer gets worse, they can't tolerate ASP2998, they start other cancer treatment, they or the doctor decides the person should stop receiving ASP2998.

Начало: 05.02.2026 Край: 30.06.2029 Възраст: от 18 г.

Japan, United States Astellas Pharma Global Development, Inc. NCT07287995

Набира участници

Remimazolam Consumption: TCI vs. Manual Infusion

Moyamoya Disease

The purpose of this prospective randomized controlled trial is to compare the total consumption of remimazolam between two different administration methods-Target-Controlled Infusion (TCI) and manual infusion-in patients undergoing cerebrovascular bypass surgery.

Начало: 04.02.2026 Край: 31.12.2030 Възраст: от 19 г.

South Korea Seoul National University Hospital NCT07377695

Набира участници Фаза 1

A Study of LY4298445 in Healthy Participants and Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)

Healthy Systemic Lupus Erythematosus Rheumatoid Arthritis

The purpose of this study is to investigate the safety and tolerability of LY4298445 in healthy participants and in participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). Participation in the study will last up to approximately 52 weeks.

Начало: 04.02.2026 Край: 01.03.2028 Възраст: 18–55 г. Фундаментална наука

Australia, China Eli Lilly and Company NCT07276958

Набира участници

NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE)

Postpartum Depression (PPD) Self-Efficacy Parental Anxiety Engagement, Patient +2

The study's objective is to conduct a Phase II randomized controlled trial examining the preliminary efficacy of the VoiceLove app compared to usual care on maternal postpartum depression in mothers with infants admitted to the Neonatal Intensive Care Unit (NICU). Primary aim: Assess the effects of VoiceLove on maternal postpartum depression, measured by the Edinburgh Postnatal Depression Scale (EPDS). The estimates from this study will be used for a future definitive Phase III trial. Secondary aim: Assess feasibility, acceptability, and patterns of communication and engagement among mothers, partners, and NICU clinicians during the NICU hospitalization, measured through app usage metrics, satisfaction surveys, and qualitative interviews. Additionally, we will evaluate effects of infant length of stay.

Начало: 04.02.2026 Край: 01.01.2028 Възраст: от 18 г.

United States Vanderbilt University Medical Center NCT07214597

Набира участници Фаза 2

INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes

Type 1 Diabetes Mellitus

INHALE-1st is a Phase 2, single-arm, multi-center, clinical study evaluating the safety and efficacy of Afrezza in combination with subcutaneously-injected basal insulin (BI) for youth 10 to \

Начало: 04.02.2026 Край: 01.09.2027 Възраст: 10–17 г.

United States Mannkind Corporation NCT07224321

Набира участници Фаза 2

Efficacy of Rifaximin With NAC in IBS-D

IBS (Irritable Bowel Syndrome) IBS-D (Diarrhea-predominant)

The purpose of this study is to examine the effectiveness of using a combination of a drug, rifaximin and a dietary supplement, N-acetyl-L-cysteine (NAC), to treat patients with irritable bowel syndrome with diarrhea (IBS-D). Rifaximin is one of the standard treatments for IBS-D and is FDA approved. While rifaximin is safe and effective for treating symptoms in patients with IBS-D, many patients find that their symptoms may not completely resolve, or may come back after a period of time. This research study is designed to test the investigational use of a combination of rifaximin and NAC. The combination of rifaximin and NAC is not approved by the U.S. Food and Drug Administration (FDA) for the treatment of IBS-D, and the effects of taking both medications together are unknown. However, the two medications are approved for use separately, as detailed below. Rifaximin is the only antibiotic approved by the FDA for the treatment of IBS-D. Rifaximin (at a dose of 550 mg by mouth three times daily for 14 days) is approved by the FDA for the treatment of IBS-D. Rifaximin (at a dose of 200 mg per mouth three times daily for 3 days) is FDA approved for the treatment of traveler's diarrhea. Rifaximin at a dose of 200 mg per mouth three times daily is not approved by the FDA for the treatment of IBS-D. NAC is approved by the FDA to treat acetaminophen overdose (72-hour oral and 21-hour intravenous (IV) regimens), and for use in breaking up mucus in the lungs in patients with chronic obstructive pulmonary disease (COPD) and other lung conditions such as bronchitis. NAC is also available over-the-counter in 600 mg and 900 mg capsules as a dietary supplement, although over-the-counter use is not regulated by the FDA. This study will utilize the 600 mg dietary supplement capsules. The Investigators want to know if using a combination of rifaximin and NAC will give better results in decreasing IBS-D symptoms than using rifaximin alone. As NAC is used to break up mucus in the lungs, and the Investigators want to see if this can also break up the mucus layer in the small intestine, and therefore potentially increase the effectiveness of rifaximin. The Investigators will be testing 2 doses to determine which dose is most effective. participants are being asked to take part in this research study because participants were diagnosed with IBS-D.

Начало: 04.02.2026 Край: 01.01.2027 Възраст: от 18 г.

United States Mark Pimentel, MD NCT06727422

Набира участници Фаза 3

A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma

Multiple Myeloma

The purpose of this study is to evaluate how well JNJ-79635322 works when compared with an anti-B-cell maturation antigen (BCMA)xCD3 bispecific antibody.

Начало: 04.02.2026 Край: 30.09.2031 Възраст: от 18 г. Лечение

Australia, Brazil, Israel +2 Janssen Research & Development, LLC NCT07258511

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